Alcohol-focused and transdiagnostic treatments for unhealthy alcohol use among adults with HIV in Zambia: A 3-arm randomized controlled trial

Michael J Vinikoor, Anjali Sharma, Laura K Murray, Caleb J Figge, Samuel Bosomprah, Chipo Chitambi, Ravi Paul, Tukiya Kanguya, Suilanji Sivile, Van Nghiem, Karen Cropsey, Jeremy C Kane, Michael J Vinikoor, Anjali Sharma, Laura K Murray, Caleb J Figge, Samuel Bosomprah, Chipo Chitambi, Ravi Paul, Tukiya Kanguya, Suilanji Sivile, Van Nghiem, Karen Cropsey, Jeremy C Kane

Abstract

Background: Clinical and quality of life outcomes in people living with human immunodeficiency virus (PLWH) are undermined by unhealthy alcohol use (UAU), which is highly prevalent in this population and is often complicated by mental health (MH) or other substance use (SU) comorbidity. In sub-Saharan Africa, evidence-based and implementable treatment options for people with HIV and UAU are needed.

Methods: We are conducting a hybrid clinical effectiveness-implementation trial at three public-sector HIV clinics in Lusaka, Zambia. Adults with HIV, who report UAU, and have suboptimal HIV clinical outcomes, will be randomized to one of three arms: an alcohol-focused brief intervention (BI), the BI with additional referral to a transdiagnostic cognitive behavioral therapy (Common Elements Treatment Approach [CETA]), or standard of care. The BI and CETA will be provided by HIV peer counselors, a common cadre of lay health worker in Zambia. Clinical outcomes will include HIV viral suppression, alcohol use, assessed by audio computer-assisted self-interview (ACASI) and direct alcohol biomarkers, Phophatidylethanol and Ethyl glucuronide, and comorbid MH and other SU. A range of implementation outcomes including cost effectiveness will also be analyzed.

Conclusion: Hybrid and 3-arm trial design features facilitate the integrated evaluation of both brief, highly implementable, and more intensive, less implementable, treatment options for UAU among PLWH in sub-Saharan Africa. Use of ACASI and alcohol biomarkers will strengthen understanding of treatment effects.

Keywords: HIV; Phosphatidylethanol; Sub-Saharan Africa; Transdiagnostic therapy; Unhealthy alcohol use.

Conflict of interest statement

Declaration of Competing Interest All authors declare they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Copyright © 2023. Published by Elsevier Inc.

Figures

Fig. 1.
Fig. 1.
Schema for a 3-arm hybrid clinical effectiveness-implementation trial for unhealthy alcohol use among adults with HIV in Zambia.

References

    1. Kalichman SC, Simbayi LC, Kaufman M, Cain D, Jooste S, Alcohol use and sexual risks for HIV/AIDS in sub-Saharan Africa: systematic review of empirical findings, Prev. Sci 8 (2) (2007) 141.
    1. Shuper PA, Neuman M, Kanteres F, Baliunas D, Joharchi N, Rehm J, Causal considerations on alcohol and HIV/AIDS—a systematic review, Alcohol Alcohol. 45 (2) (2010) 159–166.
    1. Lazarus JV, Safreed-Harmon K, Barton SE, et al., Beyond viral suppression of HIV–the new quality of life frontier, BMC Med. 14 (1) (2016) 1–5.
    1. Schouten J, Wit FW, Stolte IG, et al., Cross-sectional comparison of the prevalence of age-associated comorbidities and their risk factors between HIV-infected and uninfected individuals: the AGEhIV cohort study, Clin. Infect. Dis 59 (12) (2014) 1787–1797.
    1. Langebeek N, Kooij KW, Wit FW, et al., Impact of comorbidity and ageing on health-related quality of life in HIV-positive and HIV-negative individuals, Aids. 31 (10) (2017) 1471–1481.
    1. Hahn JA, Woolf-King SE, Muyindike W, Adding fuel to the fire: alcohol’s effect on the HIV epidemic in sub-Saharan Africa, Current HIV/AIDS Rep. 8 (3) (2011) 172–180.
    1. Ferreira-Borges C, Parry CDH, Babor TF, Harmful use of alcohol: a shadow over sub-Saharan Africa in need of workable solutions, Int. J. Environ. Res. Public Health 14 (4) (2017) 346.
    1. Gilbert P, Ciccarone D, Gansky SA, et al., Interactive “Video Doctor” counseling reduces drug and sexual risk behaviors among HIV-positive patients in diverse outpatient settings, PLoS One 3 (4) (2008), e1988.
    1. Aharonovich E, Hatzenbuehler ML, Johnston B, et al., A low-cost, sustainable intervention for drinking reduction in the HIV primary care setting, AIDS Care 18 (6) (2006) 561–568.
    1. Asombang M, Helova A, Chipungu J, et al., Alcohol reduction outcomes following brief counseling among adults with HIV in Zambia: a sequential mixed methods study, PLoS Global Publ. Health 2 (25) (2022), e0000240.
    1. Wandera B, Tumwesigye NM, Nankabirwa JI, et al., Efficacy of a single, brief alcohol reduction intervention among men and women living with HIV/AIDS and using alcohol in Kampala, Uganda: a randomized trial, J. Int. Assoc. Provid. AIDS Care (JIAPAC) 16 (3) (2017) 276–285.
    1. Huis in ‘t Veld D, Ensoy-Musoro C, Pengpid S, Peltzer K, Colebunders R, The efficacy of a brief intervention to reduce alcohol use in persons with HIV in South Africa, a randomized clinical trial, PLoS One 14 (8) (2019), e0220799.
    1. Kane JC, Sharma A, Murray LK, et al., Efficacy of the common elements treatment approach (CETA) for unhealthy alcohol use among adults with HIV in Zambia: results from a pilot randomized controlled trial, AIDS Behav. 26 (2) (2022) 523–536.
    1. Murray LK, Dorsey S, Haroz E, et al., A common elements treatment approach for adult mental health problems in low-and middle-income countries, Cogn. Behav. Pract 21 (2) (2014) 111–123.
    1. Murray LK, Dorsey S, Bolton P, et al., Building capacity in mental health interventions in low resource countries: an apprenticeship model for training local providers, Int. J. Ment. Heal. Syst 5 (1) (2011) 30.
    1. Murray LK, Hall BJ, Dorsey S, et al., An evaluation of a common elements treatment approach for youth in Somali refugee camps, Global Mental Health. (2018) 5.
    1. Kane JC, Glass N, Bolton PA, et al., Two-year treatment effects of the common elements treatment approach (CETA) for reducing intimate partner violence and unhealthy alcohol use in Zambia, Global Mental Health. (2021) 8.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C, Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact, Med. Care 50 (3) (2012) 217.
    1. Gelberg L, Andersen RM, Leake BD, The behavioral model for vulnerable populations: application to medical care use and outcomes for homeless people, Health Serv. Res 34 (6) (2000) 1273.
    1. Kane JC, Murray LK, Sughrue S, et al., Process and implementation of audio computer assisted self-interviewing (ACASI) assessments in low resource settings: a case example from Zambia, Global Mental Health. (2016) 3.
    1. McMahon JH, Jordan MR, Kelley K, et al., Pharmacy adherence measures to assess adherence to antiretroviral therapy: review of the literature and implications for treatment monitoring, Clin. Infect. Dis 52 (4) (2011) 493–506.
    1. Byrd KK, Hou JG, Hazen R, et al., Antiretroviral adherence level necessary for HIV viral suppression using real-world data, J. Acquir. Immune Defic. Syndr 82 (3) (2019) 245–251.
    1. Vinikoor MJ, Schuttner L, Moyo C, et al., Late refills during the first year of antiretroviral therapy predict mortality and program failure among HIV-infected adults in urban Zambia, AIDS Res. Hum. Retrovir 30 (1) (2014) 74–77.
    1. Babor TF, de la Fuente JR, Saunders J, Grant M, The Alcohol Use Disorders Identification Test: Guidelines for use in, 2011.
    1. Saunders JB, Aasland OG, Babor TF, Grant M, Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption-II, Addiction. 88 (6) (1993) 791–804.
    1. Chishinga N, Kinyanda E, Weiss HA, Patel V, Ayles H, Seedat S, Validation of brief screening tools for depressive and alcohol use disorders among TB and HIV patients in primary care in Zambia, BMC Psychiat. 11 (1) (2011) 1.
    1. Inoue S, Chitambi C, Vinikoor MJ, et al., Testing the validity of the AUDIT-C and AUDIT-3 to detect unhealthy alcohol use among high-risk populations in Zambia: a secondary analysis from two randomized trials, Drug Alcohol Depend. 229 (2021), 109156.
    1. Hahn JA, Anton RF, Javors MA, The formation, elimination, interpretation, and future research needs of Phosphatidylethanol for research studies and clinical practice, Alcohol. Clin. Exp. Res 40 (11) (2016) 2292–2295.
    1. Hahn JA, Dobkin LM, Mayanja B, et al., Phosphatidylethanol (PEth) as a biomarker of alcohol consumption in HIV-positive patients in sub-Saharan Africa, Alcohol. Clin. Exp. Res 36 (5) (2012) 854–862.
    1. Anton RF, Commentary on: Ethylglucuronide and ethyl sulfate assays in clinical trials, interpretation 1 and limitations: results of a dose ranging alcohol challenge study and two clinical trials, Alcohol. Clin. Exp. Res 38 (7) (2014) 1826.
    1. Radloff LS, The CES-D scale: a self-report depression scale for research in the general population, Appl. Psychol. Meas 1 (3) (1977) 385–401.
    1. Vilagut G, Forero CG, Barbaglia G, Alonso J, Screening for depression in the general population with the Center for Epidemiologic Studies Depression (CES-D): a systematic review with meta-analysis, PLoS One 11 (5) (2016), e0155431.
    1. Kane JC, Van Wyk SS, Murray SM, et al., Testing the effectiveness of a transdiagnostic treatment approach in reducing violence and alcohol abuse among families in Zambia: study protocol of the violence and alcohol treatment (VATU) trial, Global Mental Health. (2017) 4.
    1. Mollica RF, Caspi-Yavin Y, Bollini P, Truong T, Tor S, Lavelle J, The Harvard trauma questionnaire: validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees, J. Nerv. Ment. Dis 180 (2) (1992) 111–116.
    1. Spitzer RL, Kroenke K, Williams JB, Lowe B, A brief measure for assessing generalized anxiety disorder: the GAD-7, Arch. Intern. Med 166 (10) (2006) 1092–1097.
    1. Humeniuk R, Ali R, Babor TF, et al., Validation of the alcohol, smoking and substance involvement screening test (ASSIST), Addiction. 103 (6) (2008) 1039–1047.
    1. Kane JC, Murray LK, Bass JK, Johnson RM, Bolton P, Validation of a substance and alcohol use assessment instrument among orphans and vulnerable children in Zambia using audio computer assisted self-interviewing (ACASI), Drug Alcohol Depend. 166 (2016) 85–92.
    1. Humeniuk R, Henry-Edwards S, Ali R, Poznyak V, Monteiro MG, Organization WH, The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): Manual for Use in Primary Care, 2010.
    1. Ravens-Sieberer U, Wille N, Badia X, et al., Feasibility, reliability, and validity of the EQ-5D-Y: results from a multinational study, Qual. Life Res 19 (6) (2010) 887–897.
    1. Vinikoor MJ, Zyambo Z, Muyoyeta M, Chander G, Saag MS, Cropsey K, Point-of-care urine ethyl glucuronide testing to detect alcohol use among HIV-hepatitis B virus Coinfected adults in Zambia, AIDS Behav. 22 (7) (2018) 2334–2339.
    1. Murray LK, Haroz E, Dorsey S, Kane J, Bolton PA, Pullmann MD, Understanding mechanisms of change: an unpacking study of the evidence-based common-elements treatment approach (CETA) in low and middle income countries, Behav. Res. Ther 130 (2020), 103430.
    1. Wutzke SE, Shiell A, Gomel MK, Conigrave KM, Cost effectiveness of brief interventions for reducing alcohol consumption, Soc. Sci. Med 52 (6) (2001) 863–870.
    1. Edejer TT-T, Baltussen R, Tan-Torres T, et al., Making Choices in Health: WHO Guide to Cost-Effectiveness Analysis vol. 1, World Health Organization, 2003.

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